Description

Tech Compliance Analyst II

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering—for each other, for our customers, and ultimately for the people who rely on the services we support.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

JOB RESPONSIBILITIES

Conduct in-depth assessments and evaluations of technology systems and processes to ensure compliance with relevant laws, regulations, and organizational policies (e.g., GDPR, CCPA, HIPAA).
Identify compliance gaps and recommend corrective actions to address issues.
Lead or support internal and external audits related to technology compliance, including planning, executing, and reporting on audit activities.
Prepare and review audit documentation, coordinate with auditors, and track the implementation of audit recommendations.
Perform detailed risk assessments related to technology operations and compliance.
Develop and implement risk mitigation strategies and controls to address identified risks and improve compliance posture.
Assist in the development, review, and updating of technology compliance policies, procedures, and documentation.
Ensure that policies are effectively communicated and provide training to relevant stakeholders on compliance requirements.
Investigate and analyze compliance incidents or breaches related to technology systems
Develop and implement corrective and preventive measures to resolve compliance issues and prevent recurrence.
Analyze compliance data and trends to generate actionable insights and support decision-making. Prepare detailed reports on compliance status, audit findings, risk assessments, and other relevant metrics for senior management.
Collaborate with IT, legal, risk management, and other departments to ensure a cohesive approach to compliance and address cross-functional compliance issues.
Provide guidance and support to junior compliance staff and contribute to the overall success of the compliance team.
Identify opportunities for process improvements within the technology compliance function and contribute to the enhancement of compliance practices.
Stay current with industry trends, regulatory changes, and best practices to ensure the organization's compliance program remains effective and up to date.

Qualification Requirements

Bachelor's degree in information technology, Cybersecurity, Business Administration, or a related field. Relevant certifications (e.g., CISA, CISM, CISSP) are preferred.
Experience in technology compliance, information security, or a related field. Experience in a similar role or with significant project responsibility is required.
Advanced understanding of technology compliance regulations, standards, and best practices.
Strong analytical and problem-solving skills with the ability to manage complex compliance tasks.
Excellent attention to detail and organizational abilities. Effective communication and interpersonal skills, with the ability to interact with senior management and cross-functional teams. Proficiency in compliance management tools and software, and advanced knowledge of Microsoft Office Suite (Word, Excel, PowerPoint).
Ability to manage multiple projects and prioritize tasks effectively

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

The IT Compliance Analyst supports the quality and compliance activities within the Information Technology (IT) department. The primary responsibilities will include managing IT's Computer System Validation (CSV) Programs to lead and oversee site validation activities ensuring compliance with internal company validation procedures and industry regulations for validation activities. The ideal candidate will have knowledge and experience in the area of Good Clinical Practices (GCPs) guidance and applicable clinical regulations, including FDA 21 CFR part 11, as related to developing, implementing, validating, maintaining and supporting assigned computerized systems in order to ensure that operations are implemented and maintained in a compliant state.